New FDA Guidance Embraces “Remote Interactive Evaluations” but Stops Short of Permitting Virtual 704(a) Inspections

On April 14, 2021, the U.S. Food and Drug Administration issued formal guidance addressing the circumstances under which it will conduct “remote interactive evaluations” of drug manufacturing and bioresearch monitoring facilities in light of the ongoing COVID-19 public health emergency, which has pushed many previously in-person activities onto virtual platforms over the past 13 months.

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